|
Device | META DDDR MODEL 1256 PULSE GENERATOR |
Generic Name | implantable pacemaker Pulse-generator |
Regulation Number | 870.3610 |
Applicant | ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 15900 Valley View Ct. Sylmar, CA 91342 |
PMA Number | P900070 |
Supplement Number | S016 |
Date Received | 02/11/1997 |
Decision Date | 08/07/1997 |
Withdrawal Date
|
06/20/2007 |
Product Code |
DXY |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR EXTENSION OF SHELF LIFE FROM 12 MONTHS TO 18 MONTHS |